Oncology Research Specialist - Regulatory Affairs

Overview

Job Summary

Coordinates regulatory and research compliance related activities and documentation for clinical trials conducted by Levine Cancer Institute; follows industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH.

Essential Functions

• Assists with regulatory and other compliance documentation associated with oncology research projects/clinical trials.
• Participates in the study start-up and maintenance activities, working with the PI and others on the delegation of research study related tasks.
• Completes and maintains protocol delegation logs and signature profiles for oncology research studies. 
• Assures all documentation is managed compliantly and in an audit-ready manner.
• Maintains appropriate documentation for assigned studies in accordance to standard procedures.
• Assists in timely filing of documents and maintains electronic data repositories and other e-systems.
• Assists in the monitoring of clinical trial compliance by reporting issues and problems appropriately.

 

Physical Requirements

 

Primarily works in a remote/home based setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in clinical trials when required to be on-site.

Education, Experience and Certifications

High School Diploma or GED required; Bachelor's Degree preferred, Health/Science preferred. Experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.